The Occlutech Figulla PFO and ASD occluder: a new nitinol wire mesh device for closure of atrial septal defects.

ABSTRACT

BACKGROUND: We investigated the safety, feasibility and efficacy of the Occlutech devices for patent foramen ovale (PFO) and atrial septal defect (ASD) closure in a prospective trial. METHODS: The retention discs of the PFO device (23 x 25 mm, 27 x 30 mm) are connected by a 3 mm waist in the center with only one right atrial side central pin. The left atrial disc is produced either with a single or double flat layer, which allows a significant reduction of meshwork material. The ASD occluder (6-40 mm, 3 mm increments) has only one central pin on the right atrial side. Indications for closure included cryptogenic stroke with evidence of a PFO on transesophageal echocardiography (TEE) or an ASD II. The devices were implanted in 29 patients with PFO and in 12 patients with ASD II (fluoroscopy and TEE). An echocardiographic follow-up examination was performed after 1, 2 and 6 months. RESULTS: The devices were successfully implanted in all 41 patients. There were no periprocedural complications. One patient with ASD II died of recurrent myocardial infarction without evidence of cardioembolic origin. TEE studies showed a residual shunt in 11.2% after 60 days in patients with PFO and a left-to-right shunt in 9.1% of the remaining patients with ASD II. After 180 days only 1 patient with PFO had a right-to-left shunt (3.7%). A residual shunt in the patients with ASD was not observed. CONCLUSIONS: The novel Occlutech devices appear to be safe, feasible and effective for PFO and ASD closure, with a significant reduction of the meshwork and absence of left atrial central pin.